Feb. 13 (UPI) -- E-cigarettes like JUUL may turn out to be effective tools for quitting smoking. But the products can also be a pathway to introduce young people to nicotine, creating a dilemma for federal regulators.
Earlier this week, he reiterated his concern that e-cigarette makers are not doing enough to stop teens from vaping after a Centers for Disease Control and Prevention report showed the number of teens who smoke -- both e-cigarettes and traditional cigarettes -- is once again rising.
But e-cigarettes are pulling in new users, who have never smoked traditional cigarettes, increasing the number of people addicted to nicotine.
Pulling in new users
In January, the FDA highlighted the contrast in falling numbers of tobacco cigarette smokers with the soaring rates of young people who vape. The agency pointed to a 67 percent drop in adults who reported smoking cigarettes every day.
That number compares with a 78 percent jump in e-cigarette use among high school students and a 48 percent increase among middle school students from 2017 to 2018 -- fueling concerns that decades of efforts to decrease nicotine dependency are going up in (vape) smoke.
"While we're very proud of this, we are very concerned that one epidemic is being swapped for another. Roughly 20 percent of kids now vape, and most of them were not smokers in the first place," Robin Koval, CEO and president of Truth Initiative, an anti-smoking non-profit group, said in a call with reporters on Tuesday.
While many e-cigarette and vape companies have received warnings from Gottlieb and the agency about keeping their products away from children, statistics show these efforts -- whatever they may be -- are failing.
The CDC on Monday reported that roughly 5 million middle and high school students have used a tobacco product in the last 30 days, up from 3.6 million in 2017.
That works out to 1 in 4 high school students and 1 in 14 middle school students.
Tobacco treated differently
Unlike the restrictions on selling flavored cigarettes -- and advertising tobacco to children, flavored e-cigarette pods are legal and have been marketed to young consumers.
"In the Tobacco Control Act, which established the FDA Center for tobacco products, all flavors of cigarettes, except menthol, were banned," Becky Wexler, spokeswoman for the Campaign for Tobacco-Free Kids, told UPI. "So it doesn't make a whole lot of sense that tobacco companies are allowed to sell e-cigarettes in thousands of kid-friendly flavors."
Gottlieb has focused on JUUL, which has amassed two-thirds of the market in the last couple of years. Altria, which manufactures Marlboro and other brands of traditional cigarettes, bought 35 percent of the company in December because of its popularity among teens and adults.
In November, JUUL promised to scale up its "secret shopper" program from 500 visits per month to about 2,000 per month to keep retailers from selling flavored e-cigarettes to kids.
JUUL stopped selling flavored pods in some stores. It also improved age-restriction verifications on websites that sell its products.
"But intent is not enough, the numbers are what matter, and the numbers tell us underage use of e-cigarette products is a problem," Burns said.
Crafting e-cigarette rules
The FDA is considering whether e-cigarettes should be approved as a smoking cessation tool.
The agency acknowledges some of the health risks associated with e-cigarette use, but believes they could be useful for helping adults quit smoking.
"We want to make sure we're asking sufficient questions about the long-term health effects of these inhaled products, especially their effect on the lungs, to ensure that they are safe for their intended use," the agency said.
Wexler said e-cigarettes shouldn't be sold online, or in flavors -- or be sold by tobacco companies.
The FDA raided JUUL's San Francisco headquarters in November, looking for information on how the company was marketing its product, especially to children.
"Here's what we'd like the FDA to do, is to make sure that companies like JUUL and others can't market their products in ways that appeal to kids," Wexler said. "Over the past year and a half, during which the epidemic was fueled, they had ads that featured people who looked like they were care-free and having fun using these products. It definitely didn't look like they were doing anything that was potentially addictive."
JUUL marketed for cessation
There are only a handful of FDA-approved products on the market for smoking cessation, and JUUL may have to seek approval in order to promote it as a therapy, but the company has moved to take advantage of its partnership with Altria.
Altria said it invested in JUUL because it is a product with potential to reduce harm from tobacco, which the company called one of its long-term goals.
"Through JUUL, we are making the biggest investment in our history toward that goal," the company said in a press release. "We strongly believe that working with JUUL to accelerate its mission will have long-term benefits for adult smokers and our shareholders."
In addition to utilizing retail shelf space and distribution assistance from Altria, Burns said JUUL is putting ads in cigarette packs and sending mail to adult smokers in the company's customer database.
"When you take a step back, our success ultimately depends on our ability to get our product in the hands of adult smokers and out of the hands of youth," Burns said. "When adult smokers try it, it works."
Gottlieb has called Burns, as well as Altria CEO Howard Willard, to FDA headquarters to explain how they plan to keep JUULs out of the hands of teens while also keeping them available to adults looking to quit smoking.